S-shaped interspinous process spacer having tight access offset hooks

ABSTRACT

An S-shaped interspinous spacer having a pair of hooks that, upon lateral insertion between opposed spinous process, bear upon the opposed spinous processes.

CONTINUING DATA

This continuation-in-part patent application claims priority fromco-pending U.S. Ser. No. 12/055,757, filed Mar. 26, 2008, entitled“Interspinous Process Spacer Having Tight Access Offset Hooks”(Hawkins).

BACKGROUND OF THE INVENTION

The leading cause of lower back pain arises from rupture or degenerationof lumbar intervertebral discs. Pain in the lower extremities is causedby the compression of spinal nerve roots by a bulging disc, while lowerback pain is caused by collapse of the disc and by the adverse effectsof articulation weight through a damaged, unstable vertebral joint.

In some cases, when a patient having a collapsed disc moves in extension(e.g., leans backward), the posterior portion of the annulus fibrosis orfolding of the ligamentum flavum may further compress and extend intothe spinal canal. This condition, called “spinal stenosis”, narrows thespinal canal and causes impingement of tissue upon the spinal cord,thereby producing pain.

There have been numerous attempts to provide relief for theseafflictions by providing a spacer that inserts between adjacent spinousprocesses present in the posterior portion of the spinal column. Thisspacer essentially lifts the upper spinous process off of the lowerspinous process, thereby relieving stenosis. In general, theseinterspinous implants are adapted to allow flexion movement in thepatient, but resist or limit extension.

U.S. Pat. No. 6,068,630 (“Zuchermann”) discloses a spinal distractionimplant that alleviates pain associated with spinal stenosis byexpanding the volume in the spinal canal or neural foramen. Zuchermanndiscloses a plurality of implants having a body portion and lateralwings. The body portion is adapted to seat between the adjacent spinousprocesses, while the wings are adapted to prevent lateral movement ofthe body portion, thereby holding it in place between the adjacentspinous processes. The designs disclosed in FIGS. 15, 80 and 84 ofZuchermann comprise central body having an integral wing. Although theZuchermann device achieves spinal distraction, it nonetheless possessessome limitations. First, since the Zuchermann central bodies have atleast one integral wing, the clinician may encounter difficulty insizing the central body independently of delivering the lateral wings.Second, the expansive geometry of the disclosed devices may not lenditself to minimally invasive surgical techniques seeking to conservemuscle mass and soft tissue in the regions adjacent the spinousprocesses.

U.S. Pat. No. 7,029,472 (Fortin) discloses a distraction device enablingmanagement of the evolving deformation of the trunk of a child duringgrowth. The device is easy to implant on account of its compact shapeand includes two rods which can be bent and deformed on the ends thereofand which are mounted on a central adjusting member which is providedwith a small hole for engaging a small tool that is designed to adjustthe distance separating the elements for attachment to the bone. Theinventive device can be locked in a position which is determined by thetightening of two screws which are disposed on the adjusting device.

U.S. Pat. No. 5,989,251 (Nichols) discloses an apparatus is disclosedfor connecting first and second elongated spaced apart spinal rods toone another which includes a first connector having structure to engagea first spinal rod at a location along the length thereof and anelongated beam having an axis extending in a direction transverse to thefirst spinal rod, a second connector having structure to engage a secondspinal rod at a location adjacent the first connector and including areception portion projecting in a direction transverse to the secondspinal rod and defining a channel for receiving the elongated beam ofthe first connector, and a locking member dimensioned and configured toengage the channel along the axis of the beam and secure the position ofthe beam with respect thereto.

U.S. Pat. No. 6,589,243 (Viart) discloses a posterior spinalosteosynthesis device for providing a transverse connection between twovertebral rods extending along a spinal segment wherein the deviceincludes pairs of hooks adapted to laterally engage the vertebra witheach pair being connected by a pair of parallel rods which areelastically bent to form a transverse arc whose ends are engaged inbores within the hooks.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided aninterspinous spacer comprising:

-   -   a) a spinal connecting member (such as a rod),    -   b) a first hook having a first body portion having a first outer        face, a first inner face defining an inner plane, a first medial        face, a first throughhole extending from the first outer face to        the first inner face, and a first flange having i) a proximal        portion extending medially and inwardly from the inner        plane, ii) a curved intermediate portion, and iii) a distal        portion extending medially from the curved intermediate portion        and towards the inner plane,    -   c) a second hook having a second body portion having a second        outer face, a second inner face defining an inner plane, a        second medial face, a second throughhole extending from the        second outer face to the second inner face, and a second flange        having i) a proximal portion extending medially and inwardly        from the inner plane, ii) a curved intermediate portion,        and iii) a distal portion extending medially from the curved        intermediate portion and towards the inner plane,        wherein the rod extends through each of the throughholes so that        the hooks are slidably disposed on the rod,        wherein the hooks are oriented so that their inner faces oppose        each other.

Preferably, the rod extends through each of the throughholes so that thehooks are slidably disposed on the rod, and the concave surfaces of thehooks are oriented to face each other.

Preferably, the rod extends through each of the throughholes so that thehooks are slidably disposed on the rod, the proximal, intermediate anddistal portions of the first flange form a first flange plane, theproximal, intermediate and distal portions of the second flange form asecond flange plane, and the first flange plane is different from thesecond flange plane.

In use, a small incision is first made on one side of the interspinousprocesses of a functional spinal unit in order to provide lateral accessto the gap located between adjacent spinous processes. Preferably, theincision used to provide lateral access to the gap spares thesupraspinous ligament that connects the spinous processes.

Concurrently, outside the patient, the dual hooks of the interspinousprocess spacer are placed onto a spinal rod of appropriate length in anorientation whereby the convex faces of the hooks face each other. Thehooks are then brought to together so that the ends of the curved flangeportions of each hook meet each other. This requires that the convexfaces of the hooks move past each other somewhat as the hooks are movedtowards the center of the rod.

The device is then placed in this condition into the incision andoriented so that the rod is substantially parallel with the spinal cord,the hooks are essentially in a coronal plane, and the ends of the flangeportions approach the gap between the opposed inner portions of twoadjacent interspinous processes. The distal ends of the flanges are thenlaterally inserted into the gap so that the distal convex portion of thefirst flange contacts and bears against the upper spinous process andthe distal convex portion of the second flange contacts and bearsagainst the lower spinous process. Next, the device is further advancedinto the gap without widening the gap. Further inserting the device intothe gap causes the concave intermediate portion of the second flange tocontact the inner portion of the upper spinous process, and the concaveintermediate portion of the first flange to contact the inner portion ofthe lower spinous process. In its final position, the concaveintermediate portion of the second flange bears against the innerportion of the upper spinous process, while the concave intermediateportion of the first flange bears against the inner portion of the lowerspinous process. When this final position is reached, the sets screwsare advanced so as to lock each hook on the rod to fix the desiredbearings of the concave intermediate portion of the each flange with therespective inner portion of each spinous process.

There are many advantages to the dual hook interspinous process spacerof the present invention.

Typically, and as shown above, the hooks of the device are inserted as apair into the gap between the spinous processes. However, in otherembodiments, the hooks can be inserted separately, one after the other.Even when inserted separately, the offset, interlocking nature of thehooks prevents the distal ends of the hooks from contacting each other.Because the ends of these hooks are aligned in a side-by-side manner,and not in an axial manner, just a single hook thickness enters the gapbetween adjacent spinous processes.

Typically, once the surgeon has achieved placed the hooks in theirdesired distracted positions, the positions are then fixed by lockingeach such hook onto a spinal rod. The locking is usually achieved bytightening a set screw located on the hook onto the rod. However, otherlocking features such as outer nuts, swage/crimp mechanisms, cam locksand press fit can be used to lock the positions of the hooks

Connecting members could be ridged or flexible, telescoping or energystoring. They could be plates, rods, springs, tubes, or unibody (as aprotuberance) with one of the hooks. They could allow rotation but nottranslation.

In some embodiments, each hook is placed on the rod and one hook isimmediately tightened prior to inserting the device into the incision.In this condition, the untightened hook is allowed to float vis-a-visthe tightened hook. Insertion and distraction are then carried out withthe hooks in this condition and the floating hook is then tightened oncedistraction is achieved.

In other embodiments, only the hook components of the device areinserted into the incision. They are initially mounted onto aninstrument that provides them with the desired insertion orientation,and also allows them to spread apart in order to distract the adjacentspinous processes. In this embodiment, the connecting members can thenbe attached, and then locked to the hooks in a subsequent step.

In yet another embodiment, an instrument could be provided that couldhold the hooks separately from the rod so that both hooks could float ona centered rod. This would allow the entire assembly to be inserted inone step.

In some embodiments, connecting members could bridge a single pair ofhooks, for relieving stenosis at a single level, while in otherembodiments, connecting members could bridge multiple pairs of hooks forrelieving stenosis at multiple levels. In some two level embodiments,two pairs of hooks are used. In some three level embodiments, threepairs of hooks are used. In some multi-level embodiments, two hookscould be provided at a first level, while a single hook could beprovided at a second level. In other multi-level embodiments, a firstsingle hook is used at a first level and a second single hook is used ata second level.

In some embodiments, the distraction instruments are designed todistract a single level. In other embodiments, the distractioninstruments are designed to distract over multiple levels.

It is often the case that there is a variation in the bony geometry ofthe spinous processes that does not lend itself to the straightforwardgeometry of the device of FIG. 1. In some embodiments, after insertionor at differing levels, the hooks can be rotated about the connectingmember's longitudinal axis in order to accommodate variations in bonygeometry, and then locked in their desired position. Alternatively, thehooks of the present invention could have a swivel mechanism that allowsthe surgeon to adjust to variations in bony geometry, In anotherembodiment, the hooks can be made of flexible materials so that theyhave flexible/spring-like qualities.

The devices of the present invention can be designed to accommodatemodularity. For example, the hooks of the present invention can bedesigned with different throats, blade widths, or connecting featureattachment angles, etc. For example, a thin superior element can beconnected to a wide inferior element; a rib could be connected to atransverse process; and a sacral lip could be connected to a lamina.

In some embodiments, the hooks of the present invention may haveextension tabs for percutaneous manipulation. Tabs could be break off orsnap on/off. Instruments could attach by twisting, clamping, screwing.

DESCRIPTION OF THE FIGURES

FIGS. 1 a-1 e show different views of the spacer of the presentinvention.

FIG. 2 a shows a perspective view of superior and inferior hookextension instruments of the present invention grasping the two hookcomponents of the spacer.

FIG. 2 b shows the assemblies of FIG. 2 a brought together forsimultaneous hook placement.

FIG. 3 shows simultaneous hook placement into the spine.

FIG. 4 shows individual hook placement into the spine.

FIG. 5 a shows rod approximation, wherein the rod is passed into thehooks either from a cephalad or caudal direction.

FIG. 5 b shows rod approximation, wherein the set screw is the holdingfeature for securing the rod to the hook.

FIG. 6 shows the hooks of the present invention distracting spinousprocesses over longer distances.

FIG. 7 shows the device of the present invention implanted in theinterspinous space.

FIGS. 8 a-8 c disclose collapsed, expanded and exploded configurationsof the spacer of the present invention having S-shaped hooks.

FIGS. 9 a-9 b disclose the lateral insertion of the spacer of FIG. 8 ainto an interspinous space.

FIGS. 10-10 b disclose assembled and exploded configurations of themulti-level spacer of the present invention having a connecting rod.

FIG. 11 discloses the spacer of the present invention having twoflexible straps.

FIG. 12 discloses a screw and the proximal ends of a pair of hooks ofthe present invention having ridged surfaces and transversethroughholes.

DETAILED DESCRIPTION OF THE INVENTION

Now referring to FIGS. 1 a-1 d, there is provided an interspinous spacercomprising:

-   -   a) a spinal connecting member, such as a rod 1,    -   b) a first hook 3 having a first body portion 5 having a first        outer face 7, a first inner face 9 defining an inner plane, a        first medial face 11, a first throughhole extending from the        first outer face to the first inner face, and a first flange 13        having i) a proximal portion 15 extending medially and inwardly        from the inner plane, ii) a curved intermediate portion 17,        and iii) a distal portion 19 extending medially from the curved        intermediate portion and towards the inner plane,    -   c) a second hook 21 having a second body portion 25 having a        second outer face 27, a second inner face 29 defining an inner        plane, a second medial face 31, a second throughhole extending        from the second outer face to the second inner face, and a        second flange 33 having i) a proximal portion 35 extending        medially and inwardly from the inner plane, ii) a curved        intermediate portion 36, and iii) a distal portion 37 extending        medially from the curved intermediate portion and towards the        inner plane,        wherein the rod extends through each of the throughholes so that        the hooks are slidably disposed on the rod, and        wherein the hooks are oriented so that their inner faces oppose        each other.

A preferred method of implanting the device of the present invention ispresented in FIGS. 2-6. Now referring to FIG. 2 a, there is provided apair of hooks 51 of the present invention that are pre-loaded onto apair of holder instruments 53 and provided in a separated condition. Nowreferring to FIG. 2 b, there is provided a pair of hooks 51 of thepresent invention that are pre-loaded onto a pair of holder instruments53 and provided in a interdigitated condition. A knob 55 is provided onthe proximal end of each holder instrument in order to tighten the hooksonto the distal ends of the holder instruments. In this FIG. 2 a-b, thisknob is located at the proximal end 57 of the holder instrument, but itcould also be located at the distal end 59 as well. In otherembodiments, the knob can be replaced with other tightening means, suchas a lever or a snap-on. In some embodiments, the cannulated shaft ofthe holding instrument possesses a pair of slots 59 running alongopposite sides of the instrument. These slots allow the rod component ofthe device to be pre-loaded onto the holder instruments and tightenedinto one of the hooks.

Now referring to FIG. 3, insertion of a pair of interdigitated hooks ofthe present invention into the spinal anatomy is demonstrated. Thehandles 61 of the holding instruments are held by the surgeon as thejoined hooks are carefully inserted together between adjacent spinousprocesses. The holding instruments are adapted to allow these hooks tofloat in one direction (or be just gently guided). In this FIG. 3, thehooks are allowed to float along the cephalad/caudal axis, and thesurgeon can manipulates them along the medial/lateral axis. In someembodiments, the rod of the present invention (not shown) can beattached by securing it to one of the hooks.

Now referring to FIG. 4, an individual hook may be implanted into thespinal anatomy by itself. Once the individual hook is implanted, thesurgeon may implant its mating hook (not shown), either at the samelevel or at a different level. The special geometry of these hooksallows the single prong hook to pass through the dual prong hook withouttheir obstructing each other.

Now referring to FIGS. 5 a-b, once the hooks have been implanted, rodapproximation is carried out. This rod can be passed into the hookseither from a cephalad or caudal direction (as in FIG. 5 a), or fromdown the middle (between the hook holding instruments). FIG. 5 a shows arod holder patterned after the rod holder of DePuy Spine's VIPER™system, which holds the rod at its end. Now referring to FIG. 5 b, theset screw 63 is the holding feature for securing the rod to the hook.Also shown is a set screw tightening instrument 65 inserted in thesuperior hook holder, which is canulated to allow the tighteningoperation. The most proximal knob 67 of the apparatus secures the setscrew in the set screw instrument prior to sliding it down the hookholding instrument.

At close distances (e.g., one level), the holding instruments can beforced apart with the use of a simple twisting spreader, by hand, or byusing typical squeeze handle distractors. Now referring to FIG. 6, thehooks of the present invention are capable of distracting spinousprocesses over longer distances. Over longer distances, it is preferredto use a rack-style distractor 69, which has the ability to providedistraction over at least 10 centimeters of separation. Thus, in theselong distance embodiments, one or more hooks could be implanted at anylevel of the spinal anatomy, with all of the hooks being connectedthrough a single rod. Joined pairs of hooks provided at the same levelcan be distracted, and/or remote pairs of hooks provided at differentlevels can be distracted. The rack distractor of FIG. 6 can push againstthe hook holder instruments at both ends, against the hook itself, oragainst a rod holder at one or both ends.

Now referring to FIG. 1 e, preferably, at least one of the hooks hasmultiple flanges so that the interspinous spacer comprises:

-   -   a) a spinal rod,    -   b) a first hook having a first body portion having a first outer        face, a first inner face defining an inner plane, a first medial        face, a first throughhole extending from the first outer face to        the first inner face, a first flange 101 having i) a proximal        portion extending medially, ii) a curved intermediate portion        105 forming a concave surface, and iii) a distal portion 107        extending medially from the curved intermediate portion, a        second flange 111 having i) a proximal portion extending        medially, ii) a curved intermediate portion 115 forming a        concave surface, and iii) a distal portion 117 extending        medially from the curved intermediate portion,    -   c) a second hook having a second body portion having a second        outer face, a second inner face defining an inner plane, a        second medial face, a second throughhole extending from the        second outer face to the second inner face, and a third flange        121 having i) a proximal portion extending medially, ii) a        curved intermediate portion 125 forming a concave surface,        and iii) a distal portion 127 extending medially from the curved        intermediate portion,        wherein the rod extends through each of the throughholes so that        the hooks are slidably disposed on the rod.

Lastly, FIG. 7 shows the device of the present invention comprisingspinal rod 1, first hook 3, and second hook 21 implanted in theinterspinous space.

In other embodiments of the present invention, two hooks of the presentinvention could be used to respectively engage a spinous process and alamina. For example, in the L5-S1 region, there can be a first hookconnected to the spinous process and a second hook having anintralaminar connection.

In other embodiments of the present invention, a drug-eluting device maybe used in conjunction with the present invention or incorporated intoor onto the device of the present invention. In one embodiment, a drugeluting device is incorporated into or onto the rod. The drugs mayinclude anti-inflammatory or pain-killing drugs.

In other embodiments, the device of the present invention may be used asa rib spreader for correcting rib deformities, particularly in pediatriccases.

The hook and rod component of the device of the present invention couldbe metal, plastic, or ceramic. They could be biodegradable. They couldbe coated for ingrowth or porous for nutrition.

If a metal is chosen as the material of construction for a component,then the metal is preferably selected from the group consisting ofnitinol, titanium, titanium alloys (such as Ti-6Al-4V), chrome alloys(such as CrCo or Cr—Co—Mo) and stainless steel.

If a polymer is chosen as a material of construction for a component,then the polymer is preferably selected from the group consisting ofpolycarbonates, polyesters, (particularly aromatic esters such aspolyalkylene terephthalates, polyamides; polyalkenes; poly(vinylfluoride); PTFE; polyarylethyl ketone PAEK; and mixtures thereof.

In some embodiments, the tube is made of a stainless steel alloy,preferably BioDur® CCM Plus® Alloy available from Carpenter SpecialtyAlloys, Carpenter Technology Corporation of Wyomissing, Pa. In someembodiments, the tube is made from a composite comprising carbon fiber.Composites comprising carbon fiber are advantageous in that theytypically have a strength and stiffness that is superior to neat polymermaterials such as a polyarylethyl ketone PAEK. In some embodiments, thetube is made from a polymer composite such as a PEKK-carbon fibercomposite.

Preferably, the composite comprising carbon fiber further comprises apolymer. Preferably, the polymer is a polyarylethyl ketone (PAEK). Morepreferably, the PAEK is selected from the group consisting ofpolyetherether ketone (PEEK), polyether ketone ketone (PEKK) andpolyether ketone (PEK). In preferred embodiments, the PAEK is PEEK.

In some embodiments, the carbon fiber comprises between 1 vol % and 60vol % (more preferably, between 10 vol % and 50 vol %) of the composite.In some embodiments, the polymer and carbon fibers are homogeneouslymixed. In others, the material is a laminate. In some embodiments, thecarbon fiber is present in a chopped state. Preferably, the choppedcarbon fibers have a median length of between 1 mm and 12 mm, morepreferably between 4.5 mm and 7.5 mm. In some embodiments, the carbonfiber is present as continuous strands.

In especially preferred embodiments, the composite comprises:

-   -   a) 40-99% (more preferably, 60-80 vol %) polyarylethyl ketone        (PAEK), and    -   b) 1-60% (more preferably, 20-40 vol %) carbon fiber,        wherein the polyarylethyl ketone (PAEK) is selected from the        group consisting of polyetherether ketone (PEEK), polyether        ketone ketone (PEKK) and polyether ketone (PEK).

In some embodiments, the composite consists essentially of PAEK andcarbon fiber. More preferably, the composite comprises 60-80 wt % PAEKand 20-40 wt % carbon fiber. Still more preferably the compositecomprises 65-75 wt % PAEK and 25-35 wt % carbon fiber.

Now referring to FIGS. 8 a-8 c and 9 a-9 b, there is provided aninterspinous spacer comprising:

-   -   a) a first spinal connecting member (not shown),    -   b) a first hook 201 comprising a first substantially S-shaped        flange 203 having i) a distal concave portion 205 forming a        first distal tip 207 and ii) a proximal convex portion 209        forming a first proximal throughhole 210 extending therethrough,        and    -   c) a second hook 211 comprising a second substantially S-shaped        flange 213 having i) a distal concave portion 215 forming a        second distal tip 217 and ii) a proximal convex portion 219        forming a second proximal throughhole 220 extending        therethrough,        wherein the first spinal connecting member extends through each        of the throughholes to connect the hooks.

FIGS. 8 a-8 c and 9 a-9 b disclose a spinal implant to be used as aspacer between interspinous processes. The implant utilizes two hooksconnected at the one end with a lockable joint. The implant is initiallylaterally inserted in a collapsed configuration (FIG. 9 a). In thisposition, the two opposite distal tips of the hooks are touching eachother, creating a “bullet-nosed” tip that requires only a minimal entryheight. Thus, the tip geometry promotes easy insertion of the implantinto the interspinous ligament. After the initial entry of the distaltips, simply pushing the spacer into the interspinous process spaceopens the implant as the implant is pushed through the interspinousspace. After initial insertion, the hooks are rotated about each otherabout the joint to expand the spacer (FIG. 9 b). A user can adjust theimplant to form a desired height; and the joint is then locked in thatposition to maintain that height.

The S-shaped nature of the implant adds a spring to flange, which, inits deployed (opened) position, allows the implant to bend or flex alittle. When a compressive force is applied to the hooks, the implantcan bend a little to slightly decrease the distance between the hooks;thus acting like a spring that restores energy. The amount of damping(and spring) force in the implant can be adjusted by varying selecteddesign parameters, including the implant material, the distance betweenthe hook and the joint, the cross-sectional geometry of the hook, andthe overall height of the implant.

Therefore, in accordance with the present invention, there is providedan interspinous spacer comprising:

-   -   a) a first spinal connecting member,    -   b) a first hook comprising a first substantially S-shaped flange        having i) a distal concave portion forming a first distal tip        and ii) a proximal convex portion forming a first proximal        throughhole extending therethrough, and    -   c) a second hook comprising a second substantially S-shaped        flange having i) a distal concave portion forming a second        distal tip and ii) a proximal convex portion forming a second        proximal throughhole extending therethrough,        wherein the first spinal connecting member extends through each        of the throughholes to connect the hooks.

Now referring to FIGS. 10 a-10 b, there is provided an interspinousspacer comprising:

-   -   a) first and second spinal connecting members (not shown),    -   b) a first hook 201 comprising a first substantially S-shaped        flange 203 having i) a distal concave portion 205 forming a        first distal tip 207 and ii) a proximal convex portion 209        forming a first proximal throughhole 210 extending therethrough,        and    -   c) a second hook 211 comprising a second substantially S-shaped        flange 213 having i) a distal concave portion 215 forming a        second distal tip 217 and ii) a proximal convex portion 219        forming a second proximal throughhole 220 extending        therethrough,    -   d) a spinal rod 221 having a throughhole 223 at each of a first        225 and second 227 end thereof,        wherein the first spinal connecting member extends through the        throughhole of the first hook and the throughhole of the first        end of the spinal rod,        wherein the second spinal connecting member extends through the        throughhole of the second hook and the throughhole of the second        end of the spinal rod.        FIGS. 10 a-10 b disclose assembled and exploded embodiments of        the multi-level spacer of the present invention having a        connecting rod. In some embodiments, as in FIGS. 10 a-b, a        spinal rod can be inserted between the two hooks to accommodate        multi-level usage. An upper hook can be joined at its proximal        end to the upper end of the rod, and a lower hook can be joined        at its proximal end to the lower end of the rod. Moreover, a kit        can be provided with different shapes of hooks and different        height of rods. A user can then assemble various hooks and rods        to fit the various anatomies and heights of the patient.

Therefore, in accordance with the present invention, there is providedan interspinous spacer comprising:

-   -   a) first and second spinal connecting members,    -   b) a first hook comprising a first substantially S-shaped flange        having i) a distal concave portion forming a first distal tip        and ii) a proximal convex portion forming a first proximal        throughhole extending therethrough,    -   c) a second hook comprising a second substantially S-shaped        flange having i) a distal concave portion forming a second        distal tip and ii) a proximal convex portion forming a second        proximal throughhole extending therethrough,    -   d) a spinal rod having a throughhole at each of a first and        second end thereof,        wherein the first spinal connecting member extends through the        throughhole of the first hook and the throughhole of the first        end of the spinal rod,        wherein the second spinal connecting member extends through the        throughhole of the second hook and the throughhole of the second        end of the spinal rod.

Now referring to FIG. 11, there is provided an interspinous spacercomprising:

-   -   a) a spinal connecting member (not shown),    -   b) a first hook 201 comprising a first flange 203 having i) a        first distal concave portion 205 forming a first distal tip 207        and ii) a first proximal portion 209 forming a first proximal        throughhole 210 extending therethrough, and,    -   c) a second hook 211 comprising a second flange 213 having i) a        second distal concave portion 215 forming a second distal tip        217 and ii) a second proximal portion 219 forming a second        proximal throughhole 220 extending therethrough, and    -   d) a first flexible strap 229 having a first 231 and second 251        end, wherein the first end of the first flexible strap is        attached to the first distal tip of the first hook, and the        second end of the first flexible strap is attached to the first        proximal portion of the first hook.    -   e) a second flexible strap 253 having a first 255 and second 257        end, wherein the first end of the second flexible strap is        attached to the second distal tip of the second hook, and the        second end of the flexible strap is attached to the second        proximal portion of the second hook,        wherein the spinal connecting member extends through each of the        throughholes to connect the hooks.

If it is desirable for the implant to resist flexion of the spine (i.e.,wherein the spinous processes move away from each other), flexiblestraps can be looped around the spinous process and attached to theimplant, as shown in FIG. 11. FIG. 11 discloses the spacer of thepresent invention having two flexible straps. These straps are initiallyrespectively attached to the distal tips of the hooks. After insertionof the implant into interspinous process space, the straps are thenlooped around the respective adjacent spinous processes, and finallyattached to the implant again. The tension in the straps can be adjustedto accommodate the amount of flexion allowed.

Therefore, in accordance with the present invention, there is providedan interspinous spacer comprising:

-   -   a) a spinal connecting member,    -   b) a first hook comprising a first flange having i) a first        distal concave portion forming a first distal tip and ii) a        first proximal portion forming a first proximal throughhole        extending therethrough,    -   c) a second hook comprising a second flange having i) a second        distal concave portion forming a second distal tip and ii) a        second proximal portion forming a second proximal throughhole        extending therethrough, and    -   d) a flexible strap having a first and second end, wherein the        first end of the flexible strap is attached to the first distal        tip of the first hook,        wherein the spinal connecting member extends through each of the        throughholes to connect the hooks.

Now referring to FIG. 12, any lockable joint can be used to connect thetwo hooks together. FIG. 12 discloses the components of a preferredlockable joint: a screw and the proximal ends of a pair of hooks of thepresent invention having ridged surfaces and transverse throughholes.The main function of the joint is to provide rotational adjustment thatcan be locked at any desired angle (or height of the implant). Onesimple joint is a hinge that can be rotated to desired angle, and lockedwith a spinal connecting member, such as a screw 233. A simple hingewould provide a single degree-of-freedom allowing rotation on thefrontal plane. Another example of a useful joint is a universal jointwith a locking mechanism. A universal joint would provide motion in twoplanes; thus, allowing for height adjustment on the frontal plane androtation on the sagittal plane to accommodate better fit into thespinous process bony contour. Another example of a useful joint is aspherical joint, such as ball-and-socket joint, which has all threedegrees-of-freedom allowing rotation in all three axes.

Therefore, in accordance with the present invention, there is providedan interspinous spacer comprising:

-   -   a) a first spinal connecting member,    -   b) a first hook comprising a first substantially S-shaped flange        having i) a distal concave portion forming a first distal tip        and ii) a proximal convex portion forming a first proximal        connector, and    -   c) a second hook comprising a second substantially S-shaped        flange having i) a distal concave portion forming a second        distal tip and ii) a proximal convex portion forming a second        proximal connector, and        wherein the first spinal connecting member contacts each of the        connectors to form a lockable joint.

To allow secure locking of the joint, the mating surfaces 235 of thejoint can be roughened to increase the friction between them.Furthermore, different geometries can be added on to the mating surfacesto increase the locking strength. As an example, radially ridgedsurfaces 237 can be added to the mating surfaces. Use of ridged surfacesallows for discrete rotational adjustment, which in turn allows discreteheight adjustment.

Therefore, the interspinous spacers of FIGS. 8 a-12 have numerousadvantages: They allow for an adjustable height that can be locked atany desired height. They provide a collapsed configuration for easyinsertion. They are provided in a single-unit design that expands insitu. They have an ability to absorb shocks and compressive forces. Theymay possess a simple locking mechanism. Lastly, they allow for insertionfrom one side only, thereby sparing the supraspinous ligament.

Therefore, in accordance with the present invention, there is provided amethod of implanting an interspinous spacer, comprising the steps of:

a) providing an interspinous spacer comprising:

-   -   i) a spinal connecting member,    -   ii) a first hook comprising a first flange having i) a first        distal concave portion forming a first distal tip and ii) a        first proximal portion forming a first proximal throughhole        extending therethrough, and    -   iii) a second hook comprising a second flange having i) a second        distal concave portion forming a second distal tip and ii) a        second proximal portion forming a second proximal throughhole        extending therethrough,    -   wherein the spinal connecting member extends through each of the        throughholes to connect the hooks,    -   wherein the hooks are oriented so that their distal concave        portions oppose each other, and    -   wherein the hooks are oriented so that their tips substantially        meet,        b) providing lateral access to a gap between opposed inner        portions of an upper and lower spinous process,        c) laterally inserting the distal tips into the gap.

1. An interspinous spacer comprising: a) a first spinal connectingmember, b) a first hook comprising a first substantially S-shaped flangehaving i) a distal concave portion forming a first distal tip and ii) aproximal convex portion forming a first proximal throughhole extendingtherethrough, and c) a second hook comprising a second substantiallyS-shaped flange having i) a distal concave portion forming a seconddistal tip and ii) a proximal convex portion forming a second proximalthroughhole extending therethrough, wherein the first spinal connectingmember extends through each of the throughholes to connect the hooks,wherein the hooks are oriented so that their tips substantially meet,wherein the hooks are rotated about each other and about the spinalconnecting member to expand the spacer.
 2. The spacer of claim 1 whereinthe first proximal throughhole extends tranversely through the firstproximal convex portion.
 3. The spacer of claim 1 wherein the hooks areoriented so that their distal concave portions oppose each other.
 4. Thespacer of claim 1 further comprising d) a flexible strap having a firstand second end, wherein the first end of the flexible strap is attachedto the first distal tip of the first hook, and the second end of theflexible strap is attached to the first proximal portion of the firsthook.